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COMPLETED Phase 2

Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.

NCT02097849 · View on ClinicalTrials.gov ↗

Study Summary

Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objective is to evaluate the immune response to vaccination with 23-valent pneumococcal polysaccharide vaccine (PPSV23) \[a mostly T cell-independent humoral response\] and meningococcal polysaccharide diphtheria conjugate vaccine, quadrivalent (MCV4) \[T cell-dependent neoantigen response\].

Interventions

  • DRUG dimethyl fumarate
  • BIOLOGICAL tetanus diphtheria toxoids vaccine
  • BIOLOGICAL 23-valent pneumococcal polysaccharide vaccine
  • BIOLOGICAL meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent)
  • DRUG non-pegylated interferon

Study Locations (14)

Ohio

  • Research Site — Akron
  • Research Site — Cleveland
  • Research Site — Dayton

Florida

  • Research Site — Fort Lauderdale
  • Research Site — Sarasota

Texas

  • Research Site — Round Rock
  • Research Site — San Antonio

Arizona

  • Research Site — Gilbert

Colorado

  • Research Site — Thornton

Indiana

  • Research Site — Indianapolis

Kentucky

  • Research Site — Lexington

Maine

  • Research Site — Auburn

Trial Details

FieldValue
Enrollment Target 71 participants
Start Date 2015-02-28
Est. Completion 2016-05-02
Phase Phase 2

Sponsor

Biogen

74 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT02097849

The ClinicalTrials.gov registry entry for NCT02097849 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 71 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Biogen, which has 74 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Relapsing Forms of Multiple Sclerosis appearing as the primary indexed condition, and to 5 interventions — of which dimethyl fumarate is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT02097849 reports 14 study locations spanning 10 distinct geographic areas — top geographies include Ohio, Florida, Texas. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT02097849 about?

NCT02097849 is a clinical study titled "Vaccination Response in Tecfidera-Treated Versus Interferon-Treated Participants With Relapsing Forms of Multiple Sclerosis.". Primary objective is to evaluate the immune response to vaccination with tetanus diphtheria toxoids vaccine (Td) in participants with relapsing forms of Multiple Sclerosis (MS) who have been treated with Tecfidera (BG00012) versus those treated with non pegylated interferon (IFN). Secondary objecti...

What is the current status of trial NCT02097849?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 71 participants. The study started on 2015-02-28. Estimated completion is 2016-05-02.

What conditions does trial NCT02097849 study?

This clinical trial studies the following conditions: Relapsing Forms of Multiple Sclerosis. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT02097849?

The interventions under investigation include: dimethyl fumarate (DRUG), tetanus diphtheria toxoids vaccine (BIOLOGICAL), 23-valent pneumococcal polysaccharide vaccine (BIOLOGICAL), meningococcal polysaccharide diphtheria conjugate vaccine (quadrivalent) (BIOLOGICAL), non-pegylated interferon (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT02097849?

This trial is sponsored by Biogen, which has 74 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT02097849 being conducted?

This trial has 14 study locations across Arizona, Colorado, Florida, Indiana, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial